To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Approves Malarone (Atovaquone/Proguanil Hydrochloride) To Prevent And Treat Malaria URL: http://www.pslgroup.com/dg/1D9B86.htm Doctor's Guide July 17, 2000
RESEARCH TRIANGLE PARK, NC -- July 17, 2000 -- Glaxo Wellcome Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Malarone™ (atovaquone and proguanil hydrochloride) for the prevention and treatment of malaria in adults and children. The drug will be available in pharmacies in mid-August. Malarone is the first new treatment for malaria discovered and developed by a pharmaceutical company in more than 40 years. Few pharmaceutical companies have invested in the discovery of anti-malarial drugs in the past four decades, but new therapies have been developed by the U.S. Army program at the Walter Reed Army Institute of Research (WRAIR). "It is gratifying to see the approval of a new antimalarial drug," said Col. Wil Milhous, Director of Antimalarial Drug Development at the WRAIR. "I am encouraged that pharmaceutical companies are committing resources to address a disease that remains a serious threat to the health of millions of people around the world." Clinical trials leading to U.S. approval of Malarone for prevention of malaria caused by P falciparum involved more than 400 adults and children (children weighing at least 24 pounds). These studies showed that Malarone was 98 percent effective in preventing malaria. The most common adverse events in people taking Malarone for prevention of malaria included headache and abdominal pain and occurred at rates comparable to placebo. For adults using Malarone for malaria prevention, the recommended dosage is one tablet daily, starting one or two days prior to entering a malaria- endemic area, one tablet a day while in the area and one tablet a day for only seven days after return. For children who weigh less than 88 pounds, a lower- dose pediatric tablet is available. Clinical trials for the treatment of acute, uncomplicated P falciparum malaria involved more than 500 adults and children (children weighing at least 24 pounds). These studies showed Malarone was 98.7 percent effective. The most common adverse events reported in over 10 percent of patients taking Malarone for treatment of malaria were abdominal pain, nausea, vomiting and headache in adults and vomiting in children. Patients with severe malaria are not candidates for oral therapy, and Malarone has not been evaluated for the treatment of severe malaria, including cerebral malaria. For adult patients with acute malaria, four tablets are administered as a single dose once daily for three days. Pediatric dosages for the treatment of malaria are adjusted by body weight. Malarone is a fixed-dose combination of two antimalarial agents, atovaquone and proguanil. Wellcome Research Laboratories, a predecessor to Glaxo Wellcome, first developed atovaquone as an antimalarial agent in the 1980s. In clinical trials, atovaquone was effective when used alone, but a recurrence of malaria was seen in some patients over time. In further clinical trials conducted in the 1990s, it was shown that when combined with proguanil, an older antimalarial drug, a cure rate of over 98 percent could be achieved. Malarone is now approved for use in more than 30 countries around the world. Malaria remains "one of the most serious and complex health problems facing humanity," according to the World Health Organization (WHO). The WHO estimates that malaria strikes 300 million to 500 million people per year, resulting in more than one million deaths, most of which are among children under the age of five. In the United States, more than 7 million people -- such as business travelers, military personnel, airline employees, vacationers and missionaries -- travel each year to malaria-endemic areas in sub-Saharan Africa, Southeast Asia, the Amazon area and the islands of the South Pacific, and more than 1,000 cases of acute malaria are reported annually in returning U.S. residents. "In certain areas of the world, parasite resistance to many of the older therapies is increasing and creating a serious public health problem," said Jeffrey Chulay, M.D., International Product Development Leader for Malarone at Glaxo Wellcome. "At the same time, more and more people -- business travelers, adventure travelers and the like -- are venturing to malaria- endemic areas. As it takes just one bite from an infected mosquito to transmit the disease, there is a continuing need for effective, well-tolerated malaria therapies to protect those travelers while overseas, or to treat them in the event they contract malaria." Related links: Glaxo Wellcome Inc. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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